Psychoneuroimmunology Therapy in Uncontrolled Diabetic Patients: A Quasi-experimental Study

NCT02536820 | Unknown Phase 3 DMC

• 1 other identifier: PNIT2015
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Psychoneuroimmunotherapy (PNIT) is the study, modification and implementation of the interactions between the processes of adaptive behavior, neurological, endocrine and immune. Among its premises assuming homeostasis or physiological balance as an integrated process involving the systems above mentioned. Additionally, among the basics theme the re-mean is introduced, ie changing the direction, the function of a concept from a negative context carry a positive meaning, so that from the PNIT no disease is seen as a problem but as a situation to solve. The patient then transmits the importance of which will come. Primary objective: To investigate whether patients on PNIT have a higher proportion of patients achieving disease control (\<7% in glycosylated hemoglobin (HBAC1) and quality of life compared with conventional treatment patients. Methodology: quasi-experimental, simple blind, simple blind, parallel, phase III clinical trial The investigators will follow a group of patients with type 2 diabetes mellitus durgin three months with an interim analysis a month after receiving the intervention (two visits) During each visit a trained PNIT physician assess the effectiveness, safety and quality of life of each patient. The investigators will include male or female patients aged 18 years-old with diabetes mellitus type II in any severity, uncontrolled (\> 7% Glycosilated Haemoglobin (HbAc1)) and any treatment regimen included. The patients are not allocated by a random process and the investigators will have a convenience sample The investigators will perform an intention to treat analysis, patients will be analyzed according to the intervention received even if this was different from the one they were assigned.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• glycosylated hemoglobin (HbAc1 %)

  3 months

Secondary Outcomes (4)

• Adverse events

  3 months

• Fasting Plasma Glucose (mmol/L)

  3 months

• Quality of life in participants in each arm

  3 months

• Follow-up lost

  3 months

Study Arms (2)

Conventional treatment + PNIT

OTHER

PNIT: Psychoneuroimmuno therapy Conventional treatment: Usual treatment that each diabetic patient recieved

Behavioral: psychoneuroimmune therapy

Conventional treatment

ACTIVE COMPARATOR

Conventional treatment: Usual treatment that each diabetic patient recieved

Drug: Conventional treatment

Interventions

psychoneuroimmune therapy BEHAVIORAL

Also known as: Solarte Technique

Conventional treatment + PNIT

Conventional treatment DRUG

Actual diabetes treatment in each participant

Conventional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who wish to participate with informed consent sign.
• Diagnosed with uncontrolled diabetes mellitus type II (\> 7% of HbAc1) at least six months before starting the study
• No change in medication at least three months before starting the study.
• Participants with acceptable electrocardiographic results acceptable at the study start.

You may not qualify if:

• Pregnant women, or planning to become pregnant during the study period.
• History of severe liver failure.
• Participants requiring elective surgeries or other procedures requiring general anesthesia for the duration of the study.
• Participants who are participating in other clinical trials involving drugs or who have participated in another clinical trial in the last three months.

Sponsors & Collaborators

• Fundación Salutia: lead
• Coomeva E.P.S: collaborator
• Sinergia: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 1, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Last Updated: September 1, 2015

Record last verified: 2015-08